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Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome


Phase 2
16 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome


The Study Drugs:

Gemtuzumab ozogamicin is designed to attach to CD33, a certain protein that is often found
in leukemia cells, causing them to die.

Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause
cancer cells to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive decitabine
through a needle in your vein over 1 and 1/2 hours on Days 1-5 of each cycle. You will also
receive gemtuzumab ozogamicin by vein over about 1 hour after you receive decitabine on Day
5 of each 4-8 week cycle.

During Cycle 1 only, if a bone marrow test done 2 weeks after you receive your first study
drug treatment shows abnormal leukemia cells, you will receive another treatment with
decitabine by vein over 1 and 1/2 hours for 5 days.

Gemtuzumab may cause allergic reactions, nausea, and vomiting. To help decrease the risk of
such side effects, you will receive Benadryl (diphenhydramine), acetaminophen, meperidine,
and hydrocortisone. You may receive these drugs by vein, or by mouth on each of the days
you get gemtuzumab ozogamicin.

Study Visits:

At every study visit, you will be asked if you have experienced side effects and to list any
drugs you may be taking.

During Cycle 1, blood (about 2 teaspoons) will be drawn at least 1 time each week for
routine tests. If the doctor thinks it is necessary, you may be asked to have additional
blood drawn.

On Day 1 of every cycle, your performance status will be recorded and your vital signs will
be measured.

On Days 1-5 of Cycle 1, your vital signs will be measured.

Between Days 12 and 16 of Cycle 1, you will have a bone marrow aspirate if you have a
diagnosis of AML or high-risk MDS to check the status of the disease. This test may be
delayed if your doctor does not think you are in remission.

During Cycles 2-3, blood (about 2 teaspoons) will be drawn for routine tests at least 2
times each month.

On Day 1 of Cycles 2 and beyond, you will have a physical exam, including measurement of
your vital signs.

During Cycles 4 and beyond, blood (about 2 teaspoons) will be drawn for routine tests at
least 1 time each month.

If the doctor thinks it is necessary, you will have a bone marrow aspirate every 1-3 months
to check the status of the disease.

You should tell the study doctor about all drugs and supplements you are taking while you
are on this study.

Length of Study:

You may receive the combination of decitabine and gemtuzumab ozogamicin for up to 6 cycles.
After this, if your doctor thinks it is in your best interest, you may continue to receive
decitabine alone for up to 24 cycles. During this part of study, your performance status
will be recorded, you will have a physical exam, and your vital signs will be measured on
Day 1 of each cycle. Blood (about 2 teaspoons) will be drawn for tests once a month. You
will be taken off study early if the disease gets worse, you experience intolerable side
effects, or your doctor thinks that it is no longer in your best interest to receive the
study drug(s).

Long-Term Follow-up:

Once you are off study, you will have follow-up visits every month for up to 2 years. At
these visits, blood (about 2 teaspoons) will be drawn for routine tests.

This is an investigational study. Gemtuzumab ozogamicin is FDA approved and commercially
available for the treatment of AML that has come back after treatment in patients over the
age of 65 years. Decitabine is FDA approved and commercially available for the treatment of
MDS. The use of gemtuzumab ozogamicin and decitabine in combination is investigational.

Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Understand and voluntarily sign an informed consent form.

2. Age >/= to 16 years at the time of signing the informed consent form.

3. Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with
refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if
not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2
or high by IPSS or >/= 10% blasts) MDS will also be eligible. All non-hematological
toxicity of previous cancer therapy should have resolved to alopecia or other toxicities not involving major organs).

4. ECOG performance status of
5. Laboratory test results within these ranges (unless due to leukemia): Serum
creatinine 2.5 x ULN or
6. Women of childbearing potential (WCBP) must have a negative urine pregnancy test
within 7 days and must either commit to continued abstinence from heterosexual
intercourse or adopting at least one highly effective method of contraception. These
methods include intra-uterine device, tubal ligation, partner's vasectomy, hormonal
birth control pills. Men must agree not to father a child and agree to use a condom
if his partner is of child bearing potential.

7. Active participants of the similar Protocol 2007-0882 (preceding study of decitabine
and Mylotarg) are eligible to roll-over to this protocol without meeting the
inclusion or exclusion criteria for this study.

8. For patients with MF only: Diagnosis of MF requiring therapy, including those
previously treated by MF-directed therapy and relapsed or refractory; or if newly
diagnosed then with intermediate or high risk according to Lille scoring system
(adverse prognostic factors are: Hb < 10 g/dl, WBC < 4 or > 30 x 10^9/L; risk group:
0 = low, 1 = intermediate, 2 = high), or with symptomatic splenomegaly (>/=10cm below
left mid-costal margin).

9. For patients with MF only: Performance status 0-2 (Zubrod).

10. For patients with MF only: Signed informed consent.

11. For patients with MF only: Patients must have been off MF-directed therapy for 2
weeks prior to entering this study and have recovered from the toxic effects (grade
0-1) of that therapy. Patients are allowed to enter the study if on stable dose, for
at least 1 months, of anagrelide (to control high platelets) or hydroxyurea (to
control high WBC or enlarging spleen), or on stable dose, for at least 2 months, of
erythropoietin (for significant anemia).

12. For patients with MF only: Serum bilirubin levels normal range for the laboratory (ULN). Higher levels are acceptable if these can be
attributed to active hemolysis or ineffective erythropoiesis, as judged by treating
physician.

13. For patients with MF only: Serum glutamic-pyruvic transaminase (SGPT) (alanine
aminotransferase [ALT]) levels treating physician.

14. For patients with MF only: Serum creatinine levels
15. For patients with MF only: Women of childbearing potential must have a negative serum
pregnancy test prior to treatment and should be advised to avoid becoming pregnant.
Men must be advised to not father a child while receiving treatment. Both women of
childbearing potential and men must practice effective methods of contraception
(those generally accepted as standard of care measures).

16. For patients with MF only: Age > 18 years.

Exclusion Criteria:

1. Pregnant or breastfeeding females.

2. Any condition, including the presence of laboratory abnormalities, which places the
patient at unacceptable risk.

3. Use of any other experimental drug or therapy for leukemia within 14 days unless
there is clear evidence of rapid disease progression. Use of hydrea to control
proliferative disease will be allowed prior to starting therapy on study and for up
to 7 days each during cycle 1-3 (Maximum daily dose of 7gm).

4. For patients with MF only: Nursing and pregnant females. Should a woman become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately.

5. For patients with MF only: Uncontrolled intercurrent illness including, but not
limited to, uncontrolled active infection, symptomatic congestive heart failure,
unstable angina pectoris, or psychiatric illness/social situations that would limit
compliance with study requirements.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Complete Remission

Outcome Time Frame:

Twice a month blood tests during Cycle 1 (one a month following), bone aspirate between days 18 to 24; up to 24 (4-6 week) cycles

Safety Issue:

Yes

Principal Investigator

Gautam Borthakur, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0288

NCT ID:

NCT00882102

Start Date:

April 2009

Completion Date:

August 2012

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Acute Myelogenous Leukemia
  • High-Risk Myelodysplastic Syndrome
  • AML
  • MDS
  • Leukemia
  • Decitabine
  • Gemtuzumab Ozogamicin
  • Dacogen
  • Mylotarg
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030